Johnson & Johnson Moves Forward on Phase 3 Coronavirus Vaccine Study

Johnson and Johnson has launched the multinational phase 3 ENSEMBLE trial for its SARS-CoV-2 vaccine candidate.

JNJ-78436735, also known as Ad26.COV2.S, is an adenovirus based candidate.

The major vaccine candidates are either adenovirus or messenger RNA based. Johnson and Johnson is evaluating both 1- and 2-dose regimens of its adenovirus vector investigational vaccine.

According to J&J, the vaccine “will be provided at a global not-for-profit basis for emergency pandemic use.”

The ENSEMBLE study follows interim results from the Phase 1/2a clinical trial which showed a safey profile and immune response the company considers worthy of further development.

“Based on these results and following discussions with the U.S. Food and Drug Administration (FDA), ENSEMBLE will enroll up to 60,000 volunteers across three continents and will study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19,” according to a company statement.

J&J reports that it has continued increasing manufacturing capabilities and has a goal of providing 1-billion doses of the vaccine annually.

The company also says it is “committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use and anticipates the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective.”

“We remain fully focused on developing an urgently needed, safe and effective COVID-19 vaccine for people around the world,” said Paul Stoffels, MD, Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “We greatly value the collaboration and support from our scientific partners and global health authorities as our global team of experts work tirelessly on the development of the vaccine and scaling up our production capacity with a goal to deliver a vaccine for emergency use authorization in early 2021.”

If successful, the vaccine is predicted at launch to remain stable for 2 years at -20 °C and at least 3 months at 2-8° C.

“This makes the vaccine candidate compatible with standard vaccine distribution channels and would not require new infrastructure to get it to the people who need it.”

On August 5, the company announced an agreement with the US government. BARDA is committing over $1 billion for the agreement, which is dependent on approval or emergency use authorization by the US Food and Drug Administration (FDA).

Development of the vaccine has been conducted in tandem with ongoing research and development collaboration with BARDA and under the oversight of the FDA.

On August 18, Brazil approved human trials for this vaccine.

On September 2, it was reported J&J had agreed in principle to supply Canada with up to 38 million doses.